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A clinical trial on the efficacy of combination therapy with immune-cell therapy(dendritic cell vaccine) and immune check point inhibitor for malignant tumor (Combination therapy with immune-cell therapy and immune check point inhibitor)

Combination therapy with immune-cell therapy and immune check point inhibitor (Combination therapy with immune-cell therapy and immune check point inhibitor)

Goto Shigenori

May. 31, 2023

0

There is no case registry.

The study is terminated due to lack of hope for case enrollment.

none

none

The study is terminated due to lack of hope for case enrollment.

Dec. 31, 2023

No

https://jrct.mhlw.go.jp/latest-detail/jRCTc031190099

Takimoto Rishu

Koshikai, Non-profit Medical Corporation

3F New Surugadai Bld. 2-1-45 Kanda-Surugadai, Chiyoda-ku Tokyo

info@j-immunother.com

Oguma Eri

Koshikai, Non-profit Medical Corporation

3F New Surugadai Bld. 2-1-45 Kanda-Surugadai, Chiyoda-ku Tokyo

+81-3-5244-5751

citeg@j-immunother.com

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

A patient MUST:
1) Be diagnosed with relapsed or advanced malignant tumor.
2) Have a measurable lesion of tumor.
3) Have an Eastern Cooperative Oncology Group performance-status score of 0 or 1.
4) Be administered immune check point inhibitor and immune-cell therapy within 4 weeks at the clinic.
5) Have an adequate function of liver, kidney, and bone marrow when the eligibility is confirmed.
6) Provide agreement of the attending doctor to participate in this study.
7) Have a backup hospital in the case of emergency.
8) Provide written consent to participate in this study.

A patient MUST NOT:
1) Have a positive result of HIV antibody.
2) Have a T cell-, NK cell-derived malingnant lymphoma/leukemia (in the case of activated immune-cell therapy).
3) Be post allogenic bone marrow transplantation.
4) Have a history of a serious adverse event due to immune check point inhibitor.
5) Be a female who is pregnant, lactating, or with a possibility of pregnancy.
6) A patient who is judged as inadequate for enrolment by doctors is excluded

Both

malignant tumor

blood collection for cell culture and tests.
combination of of immune cell administrations and immune checkpoint inhibitor infusion, total 4 times

Efficacy

Safety, Immunological response

Complete

+81-3-5244-5751

May. 26, 2023